Shiley 86108Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884522000086), received between May 27, 2020 and Jul 31, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K871204); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Disconnection

  It was reported that the endotracheal tube's hub popped off and disconnected from the tube with minimal manipulation of the ventilator circuit while staff were turning the patient. The patient had bradycardia to 40s and oxygen desaturation then code blue was called. Compression started and attempt to ventilate with an ambu bag for 2 minutes without improvement, then continued for 2 more minutes when the disconnection of the hub and tube was noticed. The hub and the tube was reconnected, then a pulse checked confirmed a return of spontaneous circulation. Bagging continued for several more minutes until O2 saturation returned to normal range, then the respiratory therapist exchanged the 3.0 hub with a 3.5 to create a more snug fit to facilitate fewer disconnections.

  Patient problems: Bradycardia; Cardiac Arrest; Low Oxygen Saturation

  MAUDE report 50107930 ↗
• MalfunctionJul 19, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19785682 ↗
• MalfunctionJul 26, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF DID NOT INFLATE. THE CUFF PRESSURE GAUGE WAS USED TO DETERMINE CUFF PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104375 ↗
• MalfunctionSep 8, 2021Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DAMAGED CONNECTOR. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY REPORTED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A DAMAGED CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441431 ↗
• MalfunctionMar 7, 2021Crack; Crack

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A BROKEN CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429832 ↗
• MalfunctionMar 5, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A CUFF INFLATION/DEFLATION ISSUE PRE-OPERATIVELY. THE CUFF WAS TESTED BY BLOWING IT WITH AIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421147 ↗
• MalfunctionOct 24, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TUBE CONNECTOR HAD PHYSICAL DAMAGED. IT WAS OBSERVED WHEN THE TUBE PREPARED WITH BALL AND WHEN UNCAPPING THE MATCH THAT GOES FROM THE TUBE TO THE ANESTHESIA CIRCUIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10731775 ↗
• InjuryMay 27, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A CUFF LEAKAGE. THE CUFF LEAKAGE OCCURRED WHILE THE PATIENT WAS INTUBATED ON THE VENTILATOR. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10091708 ↗
• InjuryMay 27, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A CUFF LEAKAGE. THE CUFF LEAKAGE OCCURRED WHILE THE PATIENT WAS INTUBATED ON THE VENTILATOR. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10091701 ↗
• InjuryMay 27, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A CUFF LEAKAGE. THE CUFF LEAKAGE OCCURRED WHILE THE PATIENT WAS INTUBATED ON THE VENTILATOR. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10090734 ↗
• InjuryMay 27, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PRODUCTS HAD BLOWN CUFF ISSUES. THE PATIENTS WERE BEING PRONED WHILE ON THE VENTILATOR. BOTH THE PATIENTS HAD PNEUMONIA AND WERE ON VENTILATORS FOR 2-3 WEEKS. THE PATIENTS WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10090718 ↗
• InjuryMay 27, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PRODUCTS HAD BLOWN CUFF ISSUES. THE PATIENTS WERE BEING PRONED WHILE ON THE VENTILATOR. BOTH THE PATIENTS HAD PNEUMONIA AND WERE ON VENTILATORS FOR 2-3 WEEKS. THE PATIENTS WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10090710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K871204. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2023 · Feb 10, 2023 · Open, Classified
  COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal in